Healthcare Industry News:  cataract 

Devices Ophthalmology Regulatory

 News Release - November 29, 2011

Visian(R) Toric ICL(TM) Approved to Market in Japan

Significant Opportunity for Expansion in Highly Myopic Japanese Market

Becomes The First Phakic IOL Approved in Japan to Correct Astigmatism

The Visian Toric ICL Available in over 50 markets and Growing over 40% Per Year

MONROVIA, Calif. , Nov. 29, 2011 -- (Healthcare Sales & Marketing Network) -- STAAR Surgical Company (Nasdaq: STAA ), the leading developer, manufacturer and marketer of minimally invasive refractive lenses, today announced that its Visian Toric Implantable Collamer® Lens has been approved by the Japanese Ministry of Health, Labor and Welfare. With this approval, the Company is able to expand its product offerings to include the Toric ICL in Japan , potentially one of its most significant markets. The Visian ICL became the first phakic lens to gain approval in Japan during 2010.

"This is a very important milestone for STAAR and we have been working very closely with the Japanese regulators to win approval for our Toric ICL," said Don Todd , President of the Asia Pacific Region. "With the high rates of myopia and astigmatism in Japan , this approval opens up a significant market opportunity for the company. Clinical studies have demonstrated that the Toric ICL can provide a superior solution for patients with myopia and astigmatism.
   Astigmatism is blurred vision which is created when the eye is unable to properly focus due to its irregular shape. An often used analogy is that where the eye is typically shaped like a basketball, in those with astigmatism, the eye is shaped more like a football. Since our distribution in Japan is direct, our gross margin for the Toric ICL will be very high making this a very attractive market for STAAR. We expect to begin shipping immediately."

According to Market Scope, 2010 Comprehensive Report on The Global Refractive Surgery Market, Japan is the third largest market in the world with 375,000 procedures performed in 2010. In Japan , approximately 30% of the population has some degree of astigmatism according to its data. Only 445 of the 11,200 ophthalmologists in Japan perform laser refractive surgery. The Visian ICL allows cataract surgeons in Japan to participate in the refractive market with a procedure that does not require an investment in capital equipment.

"It is estimated that about one third of the Japanese population has corneal astigmatism of one diopter or more," said Dr. Kimiya Shimizu , Professor and Chair of the Department of Ophthalmology at Kitasato University in Sagamihara, Japan. "Based on my experiences in high myopic cases, about two thirds of those patients have corneal astigmatism of one diopter or more so that Toric ICL will increase the patient's satisfaction. In addition, if a patient has dry eyes or thin cornea, the Toric ICL may be the only effective treatment for refractive surgery."

The Tajimi Study, published in 2007, was a random sampling of over 3,000 residents of Tajimi, Japan. The study indicated an overall rate of myopia of 41.8%, significantly higher than all other published rates of myopia worldwide. This rate compares to an estimate of 15% to 28% prevalence of myopia in other major markets. The study also found that 54% of its population had some degree of astigmatism, with 26% suffering from a very high degree of astigmatism. By comparison, according to Market Scope, the average prevalence of astigmatism in the world is about 30% with only 17% above one diopter of astigmatism.

"We implanted the first Visian Toric ICLs at our center a few weeks ago," said Dr. Minoru Tomita , Executive Director of the Shinagawa LASIK Center in Tokyo , Japan. "We are very excited about the approval of this new technology and believe that the toric version of the ICL will represent approximately 75% of our ICL procedures as we implement these procedures into our business model. The Visian ICL and Toric ICL will allow us to treat some patients who we cannot treat with currently available technology."

The Visian ICL is the market share leader amongst all phakic IOLs and over a quarter of a million ICLs have been successfully implanted. The Visian ICL and Toric ICL are marketed in over 50 countries today. This approval of the Toric ICL in Japan means the U.S. is the only major market in the world where approval is still pending. During the second half of 2010, STAAR introduced the ICL V4b which more than doubled the range of myopia which can be treated with the ICL. Earlier this year the ICL V4c gained approval in Europe. This version makes the ICL experience a one-step procedure as the need for an iridotomy is eliminated. This is accomplished by the KS-AquaPORT™ which utilizes the CentraFLOW™ technology to restore natural aqueous flow within the eye. In those markets in which the latest technology is approved, all LASIK eligible patients and more can be treated with the Visian ICL and the ICL experience is a one-step procedure like LASIK.

About STAAR Surgical

STAAR, which has been dedicated solely to ophthalmic surgery for over 25 years, designs, develops, manufactures and markets implantable lenses for the eye. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. A lens used to replace the natural lens after cataract surgery is called an intraocular lens or "IOL." A lens used in refractive surgery as an alternative to LASIK is called an Implantable Collamer® Lens or "ICL." Over 250,000 Visian ICLs have been implanted to date; learn more about the ICL at or at facebook/VisianICL or twitter/VisianICL. STAAR has approximately 300 full-time employees and markets lenses in approximately 50 countries. Headquartered in Monrovia, CA , it manufactures in the following locations: Nidau, Switzerland ; Ichikawa City, Japan ; Aliso Viejo, CA ; and Monrovia , CA. For more information, please visit the Company's website at or call 626-303-7902.

Collamer® is the registered trademark for STAAR's proprietary biocompatible collagen copolymer lens material.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including any statements about the potential effect of new product approvals on our business, the potential of new markets, any statements of belief and any statements of assumptions underlying any of the foregoing.

These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include the following: the effect of poor global economic conditions on sales, especially sales of products like the ICL used in non-reimbursed elective procedures; our limited resources to promote new products; the discretion of regulatory agencies to approve or reject new products, or to require additional actions before approval, the risk that product launches may be affected by unplanned delays or be less successful than we expect; the willingness of surgeons and patients to adopt a new product and procedure; the entrenched market position of laser-based procedures for many conditions treated by the Visian ICL; and patterns of Visian ICL use that have typically limited our penetration of the refractive surgery market. STAAR assumes no obligation to update its forward-looking statements to reflect future events or actual outcomes and does not intend to do so.

Source: STAAR Surgical

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